WASHINGTON — Food companies and restaurants may make qualified health claims linking consumption of soybean oil to reduced risk of coronary heart disease, the Food and Drug Administration announced July 31. The F.D.A. decision was issued in response to a February 2016 petition from Bunge North America, St. Louis, the North American business Bunge Ltd.

The F.D.A. said it would allow companies to communicate that soybean oil may reduce the risk of coronary heart disease and may lower LDL-cholesterol when replacing saturated fats and not increasing caloric intake.

The Bunge petition featured a summarization of human clinical trials demonstrating the heart health potential of soybean oil.

Bunge said the health claim may be used by food companies and food service operators for numerous popular products in which soybean oil is typically used, including bottled oil, dressings, dips, snacks and baked foods. Hartman Group data indicates that heart health ranks first among health features consumers seek when grocery shopping, Bunge said.

“In addition, 55% of U.S. consumers are trying to avoid or reduce saturated fat in their diet, and almost 40% are trying to incorporate healthier fats – i.e., polyunsaturated and monounsaturated fats,” Bunge said.

According to Bunge, 71 million adults in the United States have high LDL cholesterol and 15.5 million suffer from coronary heart disease.

Bunge is one of the largest soybean oil producers in the United States, and the F.D.A. decision was welcomed by Mark Stavro, Ph.D., senior director of marketing, Bunge North America.

Mark Stavro, Ph.D., senior director of marketing, Bunge North America

“Based on a compelling set of human studies from top nutrition researchers showing that soybean oil could lower LDL cholesterol when replacing saturated fat, we proactively petitioned the F.D.A. to permit the claim recognizing that enabling heart health communications for this oil would further enhance its attractiveness,” Dr. Stavro said. “The F.D.A.’s decision provides opportunities for food companies eager to develop heart healthy products, consumers looking to improve heart health, and soybean farmers who thrive when demand for their crop increases.”

While palm oil is the most consumed edible fat/oil globally, soybean oil is the most popular in the United States. In 2016-17, U.S. consumption of soybean oil is projected at 20,550 million lbs, accounting for 50% of edible/fat and oil intake. Canola oil ranks a distant second, at 15%. Still, soybean oil’s share of the edible oil market has been slipping in recent years. Ten years ago, soybean oil accounted for 62% of edible oil intake, and canola oil had a 7% market share.

Dr. Stavro told Food Business News a number of forces have contributed to the share loss. Soybean oil over time has had two principal uses — liquid oil and partially hydrogenated soybean oil, a principal source of trans fat.

He said soybean oil has lost share as users turned away from trans fats, transitioning to canola oil and palm oil (palm’s share in the United States rose to 7% from 5% over the last 10 years). Additionally, canola has benefited from a “health halo,” Dr. Stavro said thanks to a health claim for that oil approved in 2006.

Meanwhile, the image of saturated fat has been enhanced by data published in recent years indicating saturated fat intake in the diet was not associated with cardiovascular heart disease. Dr. Stavro said media coverage of this research failed to show that replacing saturated fat with healthier fats was in fact associated with reduced risk of cardiovascular heart disease.

Such replacement is advocated in the Dietary Guidelines for Americans 2010-2015.

“Intake of saturated fats should be limited to less than 10% of calories per day by replacing them with unsaturated fats and while keeping total dietary fats within the age-appropriate A.M.D.R. (acceptable macronutrient distribution ranges),” according to the Guidelines.

Soybean oil has lost share as users turned away from trans fats, transitioning to canola oil and palm oil.

Soybean oil contains 58% polyunsaturated fat of which 52% is omega-6 and 6% is omega-3.

The heart claim may be used on food and menu items containing at least 5 grams of soybean oil per serving while meeting applicable criteria for saturate fat, trans fat, cholesterol and sodium content.

The specific claims allowed by the F.D.A. are:

“Supportive but not conclusive scientific evidence suggests that eating about 1½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.”

And:

“Supportive but not conclusive scientific evidence suggests that eating about 1½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is not to increase the amount of saturated fat in the diet or the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.”

To qualify as heart healthy, soybean-oil-containing food products, including margarine, margarine substitutes and margarine products, must also be a good source of one of six beneficial nutrients identified by the F.D.A. — vitamin D, potassium, iron, calcium, protein or dietary fiber.

Soybean oil, soybean oil bends, salad dressings and shortenings may carry the claim without having to be a good source of one of these nutrients but must meet standards for saturated fat, trans fat, cholesterol and sodium content.

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